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A Phase II Dose-escalation Study Characterizing the PK of Eltrombopag in Pediatric Patients With Previously Untreated or Relapsed Severe Aplastic Anemia or Recurrent Aplastic Anemia

NCT03025698 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-03-04

No results posted yet for this study

Summary

This is a phase II, open label, multi-center, intra-patient dose escalation study to characterize the pharmacokinetics (PK) after oral administration of eltrombopag in combination with immunosuppressive therapy in pediatric patients with previously untreated or relapsed/refractory severe aplastic anemia or recurrent aplastic anemia.

Conditions

  • Aplastic Anemia

Interventions

DRUG

Eltrombopag

Tablet for oral use, once daily or Powder for oral suspension (PfOS), once daily

DRUG

hATG

Horse ATG (ATGAM) (hATG) is not considered an investigational medicinal product (IMP)

DRUG

CsA

Cyclosporine (CsA) will be by supplied as either oral capsules or oral solution, administered twice a day

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2022-04-22
Completion
2025-01-27
FDA Drug
Yes

Countries

  • United States
  • Hong Kong
  • Portugal
  • Russia
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03025698 on ClinicalTrials.gov